Implants, devices, systems, kits and methods of implanting

• US 10,470,900 B2
• Filed: 06/17/2016
• Issued: 11/12/2019
• Est. Priority Date: 06/17/2016
• Status: Active Grant

• Current Assignee: Paragon 28, Inc.
• Original Assignee: Paragon 28, Inc.
• Inventors: Dacosta, Albert, Chang, Thomas, Bono, Frank S., Raymond, Spanky
• Primary Examiner(s): Stewart, Alvin J
• Application Number:
  US15/186,005
• Publication Number:
  US 20170360577A1
• Time in Patent Office: 1,243 Days
• CPC Class Codes: A61B 17/025 Joint distractors
• CPC Class Codes: A61B 17/68 Internal fixation devices , including fasteners and spinal fixators, even if a part thereof projects from the skin bone staples A61B17/0642
• CPC Class Codes: A61B 17/8095 Wedge osteotomy devices
• CPC Class Codes: A61B 2017/00407 Ratchet means
• CPC Class Codes: A61B 2017/565 for surgical correction of axial deviation, e.g. hallux valgus or genu valgus
• CPC Class Codes: A61F 2/4225 for feet, e.g. toes
• CPC Class Codes: A61F 2/4606 of wrists or ankles; of hands, e.g. fingers; of feet, e.g. toes
• CPC Class Codes: A61F 2/4684 Trial or dummy prostheses
• CPC Class Codes: A61F 2002/30115 circular-O-shaped
• CPC Class Codes: A61F 2002/4223 Implants for correcting a flat foot
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia

Abstract

A distraction kit including at least one trial insert, at least one handle for coupling to the at least one trial insert, a correction indication guide, and at least one implant. A method for performing a distraction arthrodesis including inserting at least one trial insert into a joint and selecting a trial insert of the at least one trial insert for correction of the joint in a first plane. The method also including rotating the selected trial insert in a medial-lateral direction for correction of the joint in a second plane and selecting the needed correction in the first plane and the second plane. The method further including marking at least one bone for the selected correction. Then, marking the implant with the correction indication guide to achieve proper placement of the implant and joint correction replication from the desired trial positioning. Implants, devices, and systems are also disclosed.

Claims

1. A distraction kit, comprising:

at least one trial insert, wherein the at least one trial insert comprises;

a top surface;

a bottom surface;

a body portion extending between the top surface and the bottom surface;

at least one hole extending from an exterior surface of the body portion toward a center of the at least one trial insert;

a central mark;

at least one second mark positioned adjacent to the central mark; and

at least one third mark positioned adjacent to the at least one second mark;

wherein the top surface is angled with respect to the bottom surface;

at least one handle for coupling to the at least one trial insert via the at least one hole;

a correction indication guide, wherein the correction indication guide comprises;

at least one marking, wherein the at least one marking corresponds to at least one of the central mark, the at least one second mark and the at least one third mark of the at least one trial insert; and

at least one implant.

2. The distraction kit of claim 1, wherein the at least one second mark further comprises:

a right second mark positioned adjacent to the central mark on the right side;

a left second mark positioned adjacent to the central mark on the left side; and

wherein the at least one third mark comprises;

a right third mark positioned adjacent to the right second mark on the right side of the central mark; and

a left third mark positioned adjacent to the left second mark on the left side of the central mark.

3. The distraction kit of claim 2, wherein the at least one hole is four holes.

4. The distraction kit of claim 3, wherein a first hole is positioned between the central mark and the right second mark, a second hole is positioned between the central mark and the left second mark, a third hole is positioned between the right second mark and the right third mark, and a fourth hole is positioned between the left second mark and the left third mark.

5. The distraction kit of claim 4, wherein the first hole, the second hole, the third hole and the fourth hole are threaded.

6. The distraction kit of claim 1, wherein the at least one implant comprises:

a body comprising;

a top surface;

a bottom surface;

an exterior side surface extending between the top surface and the bottom surface; and

a recessed region positioned in the exterior side surface, wherein the recessed region corresponds to the central mark of the at least one trial insert and wherein the recessed region corresponds to at least one of the at least one markings of the correction indication guide.

7. The distraction kit of claim 6, wherein the top surface of the at least one implant is angled with respect to the bottom surface.

8. The distraction kit of claim 6, wherein the top surface and bottom surface of the at least one implant are planar relative to each other.

9. The distraction kit of claim 6, wherein the recessed region extends from the top surface to the bottom surface in the exterior side surface.

10. The distraction kit of claim 1, wherein the at least one handle comprises:

a body portion with a first end and a second end; and

a threaded portion at the first end, wherein the threaded portion is formed to couple to the at least one trial insert.

11. The distraction kit of claim 10, wherein the body portion of the at least one handle is elongated and cylindrically shaped.

12. The distraction kit of claim 1, wherein the at least one trial insert further comprises:

at least one opening extending between the top surface and the bottom surface and passing through the body portion.

13. The distraction kit of claim 12, wherein the at least one opening is positioned in a center region of the top surface and in a center region of the bottom surface.

14. The distraction kit of claim 1, wherein the at least one handle is configured to directly couple to the at least one hole.

15. A distraction kit, comprising:

at least one trial insert;

at least one handle for coupling to the at least one trial insert;

a correction indication guide, wherein the correction indication guide comprises;

a top surface;

a bottom surface opposite the top surface;

an exterior surface extending between the top surface and the bottom surface; and

at least one marking positioned on the exterior surface; and

wherein the correction indication guide has a circular cross-sectional shape and a shape of the exterior surface of the correction indication guide corresponds to a shape of an exterior surface of the at least one trial insert; and

at least one implant.

16. The distraction kit of claim 15, wherein the at least one marking of the correction indication guide comprises:

a middle marking;

a plurality of right markings positioned to the right of the middle marking; and

a plurality of left markings positioned to the left of the middle marking.

17. The distraction kit of claim 15, wherein the correction indication guide further comprises an opening, wherein the opening extends from the top surface through the bottom surface.